Pfizer says EC approves expanded indication for Prevenar 13Pfizer announced that the European Commission approved an expanded indication for the use of Prevenar 13 -- pneumococcal polysaccharide conjugate vaccine 13-valent, adsorbed -- for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older. The Summary of Product Characteristics has also been updated to include efficacy data from Pfizer’s Community-Acquired Pneumonia Immunization Trial in Adults, which demonstrated statistically significant reductions in first episodes of vaccine-type pneumococcal community-acquired pneumonia, including non-invasive/non-bacteremic CAP, and invasive pneumococcal disease in adults aged 65 and older.

Jefferies says other bidders may emerge for SalixJefferies says it could envision other bidders emerging for Salix (SLXP) and points out recent media reports have suggested Shire (SHPG) and Endo (ENDP) have considered making a bid for the company. It lists AstraZeneca (AZN) and Takeda as others who could have possible interest in Salix. The firm believes Valeant (VRX) could afford to pay more for Salix should other bidders emerge.

Pfizer announces FDA acceptance of NDA for RapamunePfizer announced that the FDA has accepted for priority review a supplemental New Drug Application for RAPAMUNE for the treatment of lymphangioleiomyomatosis, a rare, progressive lung disease in women of childbearing age that is often fatal. With the Priority Review designation for the sNDA, Pfizer anticipates a decision in June of 2015 based on the anticipated Prescription Drug User Fee Act action date. The sNDA is based on results from the Multicenter International Lymphangioleiomyomatosis Efficacy and Safety of Sirolimus Trial. The MILES Trial included 89 LAM patients with moderate lung impairment who were randomized to receive RAPAMUNE or placebo for 12 months, followed by a 12 month observation period. In the trial, those treated with RAPAMUNE for one year experienced stabilization of lung function as measured by forced expiratory volume in one second.

Tianyin JCM plans for FDA certification process Tianyin Pharmaceutical (TPI) updated on the business and development at its Jiangchuan Macrolide Facility, or JCM, active pharmaceutical ingredients operation. In addition to JCM's certification at India, along with other international clients located at Bangladesh, Philippines and Iran on import status, TPI plans for FDA certification process at its JCM facility in order to service international clients such as Pfizer's (PFE) and their subsidiaries in China, the company said. "This is expected to translate to further demand for JCM's macrolide API business in both the domestic and international markets," Tianyin stated.